Access to healthcare in childhood has long term effects on health outcomes, but many children in the US are either uninsured or underinsured, meaning they often don’t have access to the care they need. Why is that and what can we do about it?
Healthy individuals who have been vaccinated, and especially those who have been boosted, appear unlikely to develop severe infections from the omicron variant that would land them in the hospital, say medical experts who have monitored the effects of the newest coronavirus variant since it was identified over four weeks ago.
While omicron has sent U.S. infections soaring to levels not seen since last winter’s wave, it appears to have less severe effects than the delta variant, according to a handful of international studies and early data from several U.S. hospitals.
Those infected by the omicron variant are 15 to 20 percent less likely to go to an emergency room, and 40 percent less likely to be hospitalized overnight, compared with those infected with delta, according to English data analyzed by scientists from Imperial College London. That aligns with early U.S. data from some hospitals.
At the Houston Methodist hospital system, about 15 percent of symptomatic individuals have ended up hospitalized — around a 70 percent reduction compared with those infected by the delta variant, said James Musser, chair of pathology and genomic medicine.
A separate study from Britain, which is not yet peer reviewed, found that people infected with omicron were almost 60 percent less likely to enter the hospital than those infected with delta.
“What is absolutely clear is there is lower rate of hospitalization with our omicron patients in our hospital system,” Musser said. “That does not necessarily mean that this variant is quote-unquote ‘less virulent.’ The jury’s still out on that. What we know now is that … if you are immunized and, more importantly, if you are boosted, you’re going to stay out of substantial trouble.”
He and other experts warn against complacency, however, cautioning that millions of Americans, particularly the unvaccinated, remain vulnerable to more serious disease from the most transmissible coronavirus variant to date.
Other factors that might lead to greater risk include an individual’s age, the type of vaccine or booster they received, and whether they have underlying health problems, such as heart disease or obesity, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and a member of President Biden’s covid-19 transition task force.
“Have you previously had infection? Were you vaccinated? How many doses of vaccine, and was it more than six months ago? So in some ways this is almost like a calculus problem. It’s got a lot of moving parts to it and we’re trying to figure it out,” Osterholm said.
Doctors also caution that far more people will become infected with omicron simply because of its transmissibility. If even a small fraction of those land in the hospital, they worry that health care systems that are already short-staffed because of delta infections could be overwhelmed — with potentially dire results for those needing critical care as a result of car accidents, heart attacks, strokes, or any number of things that bring people to emergency rooms.
“We need to be respectful of the fact that our hospital system has been under this kind of duress for such a long time,” said Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center in Seattle. “We need to do everything we can to not allow the situation, where there’s such crowding and such intensity that we can’t optimally take care of the people who get severe disease.”
Anthony S. Fauci, Biden’s chief medical adviser, said the rapid increase in the numbers of people getting infected with the omicron variant will invariably put additional strain on the system.
“We’re going to have a real challenge to the health-care delivery system — namely the number of beds, the number of ICU beds and even the number of health care providers,” Fauci said in an interview. “Even vaccinated people are getting breakthrough infections. So if you get enough nurses and doctors infected, they are going to temporarily be out of action. And if you get enough of them out of action, you could have a double stress on the health care system.”
The welcome news for most people who are vaccinated and boosted is that omicron infections often mimic the symptoms of the common cold. Those with two shots of vaccine, but no booster, also appear to fare relatively well, though they may develop more intense symptoms that may last longer, experts said.
Of the 205 million Americans who have been vaccinated, about 66 million, or 32 percent, have received a booster dose, according to the Centers for Disease Control and Prevention.
In a series of Twitter posts, Craig Spencer, who teaches emergency medicine at Columbia University Medical Center, said every boosted patient he has seen in the emergency room has had no difficulty breathing or shortness of breath. Those who have had two doses of either the Pfizer or Moderna vaccines also have had mild symptoms, he said, “but more than those who had received a third dose.”
But almost every patient who had to be hospitalized was unvaccinated, he said.
“No matter your political affiliation, or thoughts on masks, or where you live in this country, as an ER doctor you’d trust with your life if you rolled into my emergency room at 3am, I promise you that you’d rather face the oncoming Omicron wave vaccinated,” Spencer wrote.
Children are also filling up hospital beds in many parts of the country, especially in New York. State officials issued a warning on Christmas Eve after a fourfold increase in hospitalizations in children under 18 in New York City between Dec. 5 and last week. About half of the admissions were children under 5, who are not eligible for vaccination, according to the New York Department of Health.
Experts cautioned that those at higher risk of severe infection to previous variants probably remain vulnerable to this one.
It’s not yet clear whether older, boosted individuals and those with underlying conditions, such as diabetes and heart disease, face the same lowered risk with omicron. Answering such questions is key to assessing the likely trajectory of the variant in the U.S. since it is older and less healthy than many of its global peers.
So far, though, early U.S. data echoes what has been seen in South Africa and Britain, where omicron waves are slightly ahead of this country’s.
A group of Scottish scientists said recently that vaccinated people appear to have some protection against symptomatic infection from omicron, although less than they did against delta. A third dose or booster of an mRNA vaccine was associated with a 57 percent reduction in the odds of developing a symptomatic omicron case.
In the Johns Hopkins Hospital emergency department, physicians are seeing more infections than atany other point in the pandemic, but most of the cases are not severe, said Stuart Ray, a professor of medicine in the division of infectious diseases. But he warned that there is not yet “reassuring evidence” the United States will be spared from a disruptive wave of infections and complications.
The country faces other challenges with omicron in terms of its medicine cabinet. Two of the three existing intravenous treatments called monoclonal antibodies — those from Regeneron and Eli Lilly — do not work against the variant. Some Republican governors had touted the ability of those with covid-19 to receive monoclonal antibodies, spurring some Americans to see those treatments as an alternative to getting vaccinated.
The only monoclonal antibody that does work, sotrovimab from Vir Biotechnology and GlaxoSmithKline, is in short supply and will not be available to many of those who become infected. The Food and Drug Administration authorized two easy-to-take antiviral pills last week and one has high efficacy against omicron, but it will be in initial short supply. Distribution of the pills is expected to begin shortly.
It is also unclear whether the surge in the United States will follow the same pattern as South Africa’s, which rapidly passed the peak of omicron cases last week.
South Africa’s population is significantly younger and has far lower vaccination rates, with about 35 percent of the population immunized, and virtually no oneboosted.The country also grappled with a delta variant wave that infected a far greater portion of the population than it did in the United States.
The significant number of South African residents infected with delta compared with the United States could prove to be an important distinction that might make more Americans vulnerable to omicron, said Chris Beyrer, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.
Beyrer also noted that infections in the United States, Britain and Germany seemed to be increasing at a significantly faster rate than they were in South Africa.
“This is an incredibly infectious virus and it is moving right along,” Beyrer said. He added that the United States has numerous tools — including ready access to vaccines and booster shots, the new antiviral medicines, testing and masking — that could help curb its effects.
But referring to those who have refused to follow public health guidelines, Beyrer said, “We have a lot of resistance so that makes us vulnerable to infection.”
The number of children with covid-19 recently hospitalized in New York City has increased by nearly five times this month, state officials said at a news conference Monday.
For the week from Dec. 5, 22 children with covid-19 were admitted to hospitals in the city. During a five-day period beginning on Dec. 19, that figure rose to 109, reflecting a broader national surge in coronavirus infections driven in part by the omicron variant. Daily case counts in recent days have climbed to levels not seen since last winter, when coronavirus vaccines weren’t widely available, though the total number of hospitalizations is still significantly lower.
The increase in pediatric covid patients in New York City has been mirrored nationwide. As of last week, nearly 2,000 confirmed or suspected pediatric covid patients were hospitalized nationally, a 31 percent jump in 10 days.
New York City officials are hoping a city mandate that took effect Monday requiring workers at an estimated 184,000 businesses to get at least one vaccine dose will curb infections. “We need more and more people vaccinated,” Mayor Bill de Blasio (D) told reporters. “We need to keep doubling down on vaccination to get out of the covid era once and for all.”
De Blasio’s office announced the mandate earlier this month, just days after health officials disclosed the first case of the more transmissible omicron variant in the United States. But the mayor leaves office in a few days. Kathryn Wylde, president of the Partnership for New York City, a major corporate advocacy group, said she hopes Mayor-elect Eric Adams (D) will show flexibility in enforcement, the Associated Press reported.
Roughly 92 percent of the city’s adult population has received at least one dose of a vaccine, municipal data show, while 83 percent of adults are considered fully immunized. Youth vaccination rates remain lower: Nearly half the children ages 5 to 17 have not yet received a single dose, according to the city government.
A first COVID shot will give kids some protection, but none of them will be fully vaccinated until the beginning of December.
For many, many months now, 7-year-old Alain Bell has been keeping a very ambitious list of the things he wants to do after he gets his COVID-19 shots: travel (to Disneyworld or Australia, ideally); play more competitive basketball; go to “any restaurants that have french fries, which are my favorite food,” he told me over the phone.
These are very good kid goals, and they are, at last, in sight. On Tuesday evening, about as early as anyone in the general public could, Alain nabbed his first dose of Pfizer’s newly cleared pediatric COVID-19 vaccine. The needle delivered “a little poke,” he said, but also a huge injection of excitement and relief. Since his father, a critical-care physician, was vaccinated last December (the first time I interviewed Alain), “I’ve been impatient,” Alain said. “I really wanted to get mine.” Now he is finally on his way to joining the adults. When he heard on Tuesday that his shot was imminent, he let out a scream of joy, at “a pitch I have never heard him use before,” his mother, Kristen, told me.
There’s an air of cheer among the grown-ups as well. “It’s cause for celebration,” says Angie Kell, who lives in Utah with her spouse and their soon-to-be-vaccinated 6-year-old son, Beck. Their family, like many others, has been reining in their behavior for months to accommodate their still-vulnerable kid, unable to enjoy the full docket of post-inoculation liberties that so many have. Once Beck is vaccinated, though, they can leave mixed-immunity limbo: “We might have an opportunity to live our lives,” Kell told me.
The past year has been trying for young children, a massive test of patience—not always a kid’s strongest skill. And there’s yet another immediate hurdle to clear: the plodding accumulation of immunological defense. Alain has another 15 days to go until his second dose; after that, it’ll be two more weeks before he reaches a truly excellent level of protection. Only then, on December 7, will he count as fully vaccinated by CDC standards and be able to start adopting the behavioral changes the agency has green-lit. In the intervening weeks, he and the many other 5-to-11-year-olds in his position will remain in a holding pattern. Their wait isn’t over yet.
The timing of this semi-immune stretch might feel particularly frustrating, especially with the winter holidays approaching: At this point, essentially no young kids are slated to be fully vaccinated by Thanksgiving or Hanukkah, except the ones who were enrolled in clinical trials. One shot can offer a level of protection, but experts advise waiting to change behavior for a reason—the extra safeguards that set in about two weeks after the second shot really are that much better, and absolutely worth sitting tight for.
“It takes time for immune cells to get into a position where they’re ready to pounce,” Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security, told me. COVID-19 vaccines teach immune cells to thwart the coronavirus, a process that, like most good boot camps, takes many days to unfold. The second shot is essential to clinch the lesson in the body’s memory, encouraging cells to take the threat more seriously for longer. Immune cells also improve upon themselves over time—the more, the better in these early stages. Gronvall’s own 11-year-old son is also about to get his first shot, and she doesn’t want to risk stumbling so close to the finish line. “I can’t know exactly what his immune system is going to do” after the first dose alone, she said.
Evidence from Pfizer’s original clinical trial, conducted only in adults, hinted that a first, decent defensive bump takes hold after the first shot. Kit Longley, Pfizer’s senior manager of science media relations, pointed to those data when I asked how kids at various points along the vaccination timeline should be approaching behavioral change. “Protection in the vaccinated cohort begins to separate from the placebo arm as early as 12 to 14 days after the first dose,” he told me.
The adult clinical-trial data were collected last year, though, long before the rise of the Delta variant. A more recent study, conducted in the United Kingdom, showed that one dose of Pfizer reduced the risk of symptomatic COVID-19 by only 35.6 percent when the cause was Delta, and by only 47.5 percent with Alpha. (And remember that those numbers apply best on a population scale—not for a single, individual child.) After adding a second dose, though, effectiveness rocketed up to about 90 or 95 percent against either variant. “You really need two doses for adequate, good protection,” Samuel Dominguez, a pediatric-infectious-disease specialist at Children’s Hospital Colorado, told me.
Immunity is so far looking strong in young kids: In a recent trial of thousands of children ages 5 to 11, Pfizer’s vaccine was more than 90 percent effective at blocking symptomatic cases of COVID-19, including ones caused by Delta. Longley said Pfizer expects that the timing of protection will be similar between children and adults—a first dose should lower everyone’s risk to some degree. But the company’s pediatric trial picked up only a few COVID-19 cases; none of them occurred until about three weeks after the first dose was given, or later. So it’s hard to say anything definitive about when “enough” immunity really kicks in for kids.
Some parents are counting on a level of early protection from one shot, including my cousin Joanne Sy, whose 8-year-old son, Jonah, received his first injection on Friday. “He will have good immunity after one dose,” she told me, hopefully enough to guard him on a trip they’re taking to New York for Thanksgiving two weeks from now. “We’re still going to be cautious,” Sy told me: They’ll be watching the Macy’s Thanksgiving Day Parade from a hotel room rather than the streets, and wearing masks, at least on the plane. “But we just need to move forward.”
The calculus is playing out differently for Christy Robinson of Arlington, Virginia, who will again be “hunkering down” with her husband and two daughters, June and Iris, 7 and 5, respectively, this Thanksgiving. The kids got their first Pfizer shot on Saturday, setting their household up for full, full vaccination by mid-December, just in time to hold an indoor gathering with their aunts, uncles, and cousins for Christmas. (Some quick arithmetic: To be fully vaccinated by December 25, a kid would need their first dose by November 20.) June’s also eager to “see my friends inside, because it’s cold outside,” she told me—plus go to movie theaters, and Build-A-Bear, and a trampoline park, and IHOP, and the nail salon.
By the end of this conversation, Robinson looked amused and maybe a little regretful that my question had prompted such an extravagant list. As their mother, she’s especially excited for the possibility of no longer having to quarantine her daughters after viral exposures at school. Heftier decisions are ahead too. She and her husband are still weighing whether to bring their daughters into closer, more frequent indoor contact with their grandparents, who are vaccinated but could still get seriously sick if someone ferries the virus into their midst.
And that risk—of transmitting the virus—is worth keeping in mind, with so much SARS-CoV-2 “still circulating around,” cautions Tina Tan, a pediatrician and infectious-disease specialist at Northwestern University. Immunized people are at much lower risk of picking up the virus and passing it on. There still aren’t enough of them, though, to reliably tamp down spread; uptake of shots among young kids, too, is expected to be sluggish in the months to come. Even fully vaccinated families won’t be totally in the clear while our collective defenses remain weak.
That doesn’t mean Thanksgiving has to be a bust—or even a repeat of 2020, before the vaccines rolled out. The Bells will be cautiously gathering with a few loved ones; all the adults in attendance will be immunized and everyone will get tested beforehand. “Then they can come inside the house, mask off,” Taison Bell, Alain’s father, told me. None of those measures is completely reliable on its own; together, though, they’ll hopefully keep the virus out.
The road ahead might feel a little bumpy for Alain, who’s celebrating his 8th birthday at the end of November, a few days after his second shot. (He’s getting the gift of immunity this year, his father joked.) The Bells will do something special “around when he hits full vaccination,” Kristen said, “with something Alain hasn’t gotten to do in the last two years.” But Alain, who has asthma, which can make COVID-19 worse, knows that his own injections won’t wipe the slate clean for him, or those around him. Some people in his neighborhood have caught the virus even after getting vaccinated, and he understands that he could too.
Alain will keep masking, and treading carefully at school, and even a bit at home. His 3-year-old sister, Ruby, hasn’t yet been able to get a shot. (I asked her how she felt about Alain’s vaccine; she responded, almost imperceptibly, “Jealous.”) Until another regulatory green light comes, she will still be waiting, which means that her family will be too.
Pfizer’s COVID-19 vaccine is nearly 91 percent effective at preventing symptomatic infections in children between ages 5 and 11, according to a study released by the FDA Oct. 22.
The study involved 2,268 children given COVID-19 vaccines that are one-third the dosage of the vaccines given to people ages 12 and up. They were given two doses spaced three weeks apart, the same as the adult version of the vaccine. It found that the children developed antibody levels just as strong as older children and adults given the full dosage.
The FDA’s Vaccines and Related Biological Products Advisory Committee is set to meet Oct. 26 to discuss the evidence and vote on whether to recommend FDA authorization for the shots in kids ages 5 to 11.
The CDC’s vaccine advisory panel is set to meet the first week of November to discuss recommending the shots for the age group. That means shots for kids ages 5 to 11 could be authorized in the first week of November. There are about 28 million children in the age group in the U.S.
The vaccines will come in orange capped vials to make them easily distinguishable from adult doses, according to ABC News.
Find the full study results here.
As a long hoped-for sign of the “return to normal”, most children went back to in-person learning this fall. And with the patchwork of COVID safety protocols and masking policies across school districts, classrooms became a learning lab for scientists studying the efficacy of masking and other precautions.
Unsurprisingly, getting a bunch of unvaccinated kids back together caused a surge in pediatric COVID cases. But recent Centers for Disease Control and Prevention (CDC) data from 500 counties demonstrate just how effective mask mandates have been at mitigating outbreaks.
The graphic above shows that cases in counties without school mask mandates increased at nearly three times the rate of those with mask mandates. In the five-week period spanning the start of the school year, cases in counties without a mask mandate rose by 62.6 cases per 100K children, while cases in counties with a mask mandate rose by only 23.8 per 100K. COVID outbreaks are incredibly disruptive to learning; according to a recent KFF survey, nearly a quarter of parents report their child has already had to quarantine at home this school year following a possible COVID exposure.
Even once vaccines are approved for children under 12, recent data suggest that a majority of parents will be hesitant to vaccinate their child. Just over half of 12- to 17-year-olds have received at least one dose of the vaccine so far, and only a third of parents of 5- to 11-year-olds plan to vaccinate their child right away, once the shot is approved.
Many want more information, or are worried about side effects—concerns that will best be assuaged by their pediatricians and other trusted sources of unbiased information.
Pfizer on Monday announced that testing showed that its COVID-19 vaccine was “safe” and “well tolerated” by children ages 5 to 11 and “robust neutralizing antibody responses” were observed.
The pharmaceutical company said that a “favorable safety profile” had been observed in its trial of the vaccine among children under the age of 12. For its trial, the company used doses a third of what is administered to people ages 12 and up.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer CEO Albert Bourla said.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the [Food and Drug Administration (FDA)] and other regulators with urgency,” he added.
Pfizer’s trial included 2,268 participants between the ages of 5 and 11. According to the company, the doses resulted in side effects comparable to what was observed among the trial for patients ages 16 to 25. It also said that it expects to include its results in an upcoming submission to the FDA for emergency use authorization.
In the U.S., no COVID-19 vaccines have been approved for children under the age of 12, leaving many children and the adults who are in close proximity to them particularly vulnerable during the most recent surge brought on by the delta variant.
National Institute of Health Director Francis Collins on Sunday said he believed parents and teachers should be placed in the same category as health care workers in terms of COVID-19 risk, due to their close contact with children who are ineligible to be vaccinated.
In August, the number of pediatric hospitalizations in the U.S. due to COVID-19 reached a record high of nearly 2,000. While children are generally believed to be less likely to develop severe cases of the coronavirus, new variants continue to pose the potential threat of causing more severe symptoms.
This announcement comes shortly after an advisory panel for the FDA voted last week in favor of recommending a third dose of the Pfizer-BioNTech vaccine for people over 65 and in certain high-risk groups. The panel voted against administering a third dose to all vaccine-eligible people.
According to the Centers for Disease Control and Prevention, nearly 75 percent of the eligible population — ages 12 and up — has received at least one dose of a COVID-19 vaccine. Around 64 percent of those over the age of 12 are fully vaccinated.
The Food and Drug Administration cleared the first coronavirus vaccine for emergency use in children as young as 12 on Monday, expanding access to the Pfizer-BioNTech shot to adolescents ahead of the next school year and marking another milestone in the nation’s battle with the virus.
The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.
“Adolescents, especially, have suffered tremendously from the covid pandemic. Even though they’re less likely than adults to be hospitalized or have severe illness, their lives really have been curtailed in many parts of the country,” said Kawsar R. Talaat, an assistant professor of international health at the Johns Hopkins Bloomberg School of Public Health. “A vaccine gives them an extra layer of protection and allows them to go back to being kids.”
Expert advisers to the Centers for Disease Control and Prevention are scheduled to meet Wednesday to recommend how the vaccine should be used in that age group, and the vaccine can be administered as soon as the CDC director signs off on the recommendation.
In a news briefing Monday evening after the announcement, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots.
Children rarely suffer serious bouts of covid-19, the illness caused by the coronavirus. But there is no way to predict the few who will become dangerously sick or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, about 300 have been people under 18 — a tiny fraction of the total. But that exceeds the number of children who die in a bad flu season.
Children appear to be less efficient at spreading the virus, although their role in transmission is still not fully understood — another reason for pediatric vaccinations.
Clinicians also worry that with a new virus with many unknowns, the possibility exists for long-term impacts of infection, even from the mild or asymptomatic courses of illness common among children.
The Pfizer-BioNTech vaccine, already authorized for adolescents 16 and older, was the first to be tested in younger adolescents. The FDA’s decision will provide a potential path for other vaccine-makers to follow, most of which have launched or plan to initiate trials of their vaccines in teenagers and younger children.
The agency based its authorization on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults. Researchers took blood samples and measured antibody levels triggered by the shots and foundstronger immune responses in the teens than those found in young adults. There were 16 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.
Robert W. Frenck Jr., the researcher who led the adolescent trial at Cincinnati Children’s Hospital Medical Center, said the study was designed to test whether it triggered immune responses, not whether it prevented disease. But because of the number of children who became ill in the placebo arm of the trial, it also became evident the vaccine offered robust protection.
“That really points out how much covid there is in the adolescent community,” Frenck said.
The data has not been published or peer-reviewed, but Kathryn M. Edwards, a pediatric infectious-disease specialist at Vanderbilt University Medical Center, said the results announced by Pfizer were “pretty exciting — it looked very effective and the immune responses were really good.”
Edwards said she is comfortable the benefits of vaccinations are clear among teens, noting that while children, in general, are at lower risk of severe covid-19 than adults, older adolescents seem to be more like adults in their risk for covid-19 than the very youngest children.
Audrey Baker, 15, and Sam Baker, 12, rolled up their sleeves for shots in the Pfizer-BioNTech trial at Cincinnati Children’s Hospital Medical Center. Audrey said she had no hesitation about signing up, and misses little things about how life used to be — eating out in restaurants and seeing family.
“I just trusted the science,” Audrey said. “I knew it was tested in adults. I was really just joining, hoping that maybe I could get vaccinated and help out science.”
Sam said he was more hesitant, in part because participating meant many follow-up lab tests. But he decided to do it and thinks he may have gotten the vaccine in the trial because he developed a headache and fever after his second dose.
Their mother, Rachel Baker, said she felt relief because of Sam’s symptoms.
“The biggest benefit has been that I feel a weight off my shoulders,” Rachel said. “We haven’t changed how we do anything. … We’re still masking, we’re still social distancing, but we’re a bit calmer about it all.”
H. Cody Meissner, a pediatrician at Tufts Medical Center and a member of an external advisory committee to the FDA, said he thinks a pediatric vaccine is needed. But he said he would like to see more safety data because the messenger RNA technology at the core of vaccines from Pfizer-BioNTech and the biotechnology company Moderna does not have a long, established safety record, and its first large-scale use began in December.
Meissner abstained from the December vote that overwhelmingly recommended authorization of the Pfizer-BioNTech vaccine for people 16 and older, because he thought the vaccine should be authorized in people 18 and older.
“For those who are eager to get it, it’s important for them to understand that this is very rarely a severe disease in young adolescents, number one, and this is an entirely new vaccine,” Meissner said. “I just don’t want people to get too swept up in fear of hospitalization and death from covid-19 for the first few decades of life.”
But many other physicians take comfort knowing that 250 million shots of messenger RNA vaccine have been given in the United States alone. Serious side effects, such as a risk of anaphylaxis, are extremely rare. Because the trial in teens was an “immune bridging” trial designed to test whether the vaccine triggered immune responses similar to those in adults, researchers did not need to recruit tens of thousands of people to see if those who received a vaccine were protected against illness. The immune bridging technique is commonly used to expand access to vaccines that have been proved effective and safe to adolescents or other populations.
The expansion of eligibility to children will probably ignite debates in families about when to get vaccinated, and among policymakers about whether it should be required.
Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, said she thinks it is unlikely children will be mandated to receive a coronavirus shot until the vaccines win full approval and not just emergency use authorization.
She predicted that acceptance of the vaccine will evolve as more children are vaccinated and depend on the state of the pandemic. She noted that when vaccines are introduced, the rollout often starts slowly before accelerating.
“Nervousness about a new vaccine is normal, especially when it’s for kids,” Reiss said. “Parents that are nervous now might feel different in a few months, once their friends’ kids have gotten vaccinated. And the views of the kids are also going to matter — if teens are going to think this is going to make their lives easier.”
Opening up vaccinations to children may sharpen a debate unfolding globally about the equity of vaccine access. Talaat said that while she can’t wait for her kids to have access to a vaccine, she is troubled by the global inequities as high-risk front-line workers or older people still don’t have access to vaccines in countries where the coronavirus is out of control.
Moderna announced Thursday that an initial analysis of its teen trial found its vaccine was 96 percent effective among participants who received at least one dose. Moderna is in discussions with regulators about the data. Pfizer-BioNTech and Moderna are testing their vaccines in children as young as infants. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.
Trials in younger children are expected to take longer, because researchers must step down gradually in age and determine a safe and effective dose. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said data from tests in children as young as 2 years old may be available by September or October, with data on children as young as 6 months possible by the end of the year.
Within each age category, a separate risk-benefit assessment may take place. In the youngest children, given the low risk from the coronavirus, side effects may figure more prominently into the analysis, for example. Researchers may end up choosing a lower dose of vaccine. The understanding of children’s role in transmission may also evolve and help guide vaccine use and public policy.
“We are proceeding carefully, cautiously,” Edwards said. “We’re using the same rigid guidelines we use in all vaccines, and we take this very seriously. I think as time goes on and more information becomes available, some of the questions may be easier to address.”